Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Clinical Quality Assurance Program Manager in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Program Manager working on the R&D Quality Assurance team, you will be empowered to lead Clinical Quality Assurance (CQA) activities for assigned clinical development programs, and a typical day will include:
Lead the management of audits, quality issues and investigations, and inspections. This position requires sufficient understanding, experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities with supervision.
Provide expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
Liaise with various Takeda R&D functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.
Manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations.
Under supervision, provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership
Under supervision, develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures.
Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
Assist with investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
Provide GCP compliance support during inspections of investigator sites and Takeda. Assist with development of appropriate and timely inspection responses and follow-up actions
Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple compounds, Takeda sites, or functional groups.
Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.
Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
Perform additional GCP related activities upon request by CQA management
At Takeda, we start our discussions with this question. And the answer is, we put patients first. Since 1781, we have been placing their health, well-being, and trust in us at the heart of everything we do. To better serve their needs, we focus our world-class research and development on three core therapeutic areas: gastroenterology, oncology, and neuroscience, and we also develop life-saving vaccines. As a member of our global team, you’ll be part of our unwavering commitment and inspiring mission to strive towards better health and a brighter future for people worldwide through leading innovation in medicine. To help us achieve our mission, we will empower you to shine at every step of the way.